Recall Z-0745-2017— Becton Dickinson & Company

Name: FDA recall Z-0745-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-08

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2016-08-08. It names one FDA 510(k) clearance: K030573. Product: BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.. Reason: BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Ongoing
Initiated: 2016-08-08
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K030573 — BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341Bd Vacutainer Systems Preanalyical Solutions·cleared 2003-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.

Reason for recall

BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.

Data sourced from openFDA. This site is unofficial and independent of the FDA.